OTC Medication Information: Clotrimazole

CLOTRIMAZOLE- clotrimazole cream
TOP CARE (Topco Associates LLC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Clotrimazole, USP 1%

)

Purpose

Antifungal

Uses

  • treats most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort

Warnings

For external use only

Do not use

on children under 2 years of age, unless directed by a doctor.

When using this product,

avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foots and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

  • store at room temperature 20º-25ºC (68º-77ºF)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Question or comments?

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Principal display panel

COMPARE TO LOTRIMIN® AF ATHLETE’S FPPT CREAM ACTIVE INGREDIENT*

Athlete’s Foot Cream

Cure Most Athlete’s Foot

RELIEVES:

  • Itching
  • Burning
  • Cracking
  • Scaling
  • Proven Clinically Effective in the Treatment of Most Athlete’s Foot
  • Soothes Itching and Burning

NET WT. OZ (g)

*This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete’s Foot Cream.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Package label

Clotrimazole, USP 1%
(click image for full-size original)

TOPCARE HEALTH Athlete’s Foot Cream

CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-508
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECANOL
POLYSORBATE 60
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SORBITAN MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-508-01 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (36800-508-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 09/30/2021
Labeler — TOP CARE (Topco Associates LLC) (006935977)

Revised: 07/2021 TOP CARE (Topco Associates LLC)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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